MDR – MDCG update
The European commission has published two additional MDCG Guidance documents last week. MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories.
MDCG 2019-3 Interpretation of Article 54(2) b rev.1 (Exempt devices from the premarket clinical evaluation consultation procedure).
FDA – GUDID Update
The FDA has updated their Data Elements Reference Table and the corresponding HL7 implementation file, which might require adaption of your GUDID upload procedure.
APAC Region EUA Information
Several Countries in the APAC Region are still working on an Emergency Use Authorization (EUA) for Products during the COVID-19 pandemic.
Handling of Notarization and apostille could be difficult during the COVID-19 situation. The applicant may submit application for import license with such document which is self-attested and will be submitted notarized or apostilled later.
The SFDA has updated and published some guidance documents:
- MDS-G47 Guidance on Requirements for Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories – Recognized Standards
- Guidance on General Requirements for Medical Devices Manufacturing
- MDS – G46 Guidance on Requirements for Medical Masks - Recognized Standards
PMDA implemented an organizational restructuring of Office of International Programs on April 1, 2020.
The Taiwan FDA published a set of pdf files for the draft of "Setting Standards for Medical Device Manufacturers" in May 2020.
The Ministry of Health Malaysia has published DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT “MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION” for public comment.
All updates compiled in one PDF file:
You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.